Go Beyond Notification of Breast Density to Prevent False Negatives

The main cause of false negatives on mammograms is high breast density, which can make breast lesions more difficult to identify.¹ This is a major concern because almost half of the women screened for breast cancer are classified as having either heterogeneously dense or extremely dense breast tissue.² The American College of Radiology (ACR) recommends several breast density resources on its website.

Medical Liability Risk Management Recommendations

Notification of breast density cannot be relied upon to protect radiologists from liability when breast density or some other breast condition makes the identification of breast lesions more difficult.

Consider the following recommendations:^3,4,5,6,7

• Obtain and review the patient’s clinical information.
  • Consider dense breast tissue in association with other patient risk factors.
• Do not rely on screening views alone to diagnose a palpable mass; complete the evaluation with diagnostic mammography and ultrasound.
• If results are equivocal, recommend a repeat study, using additional views and other imaging modalities as appropriate.

• Optimize image quality (e.g., carefully position the patient and follow technical requirements).
  • If technical quality is poor, repeat the study.
• Optimize interpretation accuracy.
  • Ensure that there is optimal lighting for viewing images.
  • Read mammograms in an environment where distractions and interruptions are minimized.
• Whenever possible, compare results of the present study to multiple prior studies.
• Review prior studies after interpreting the current study to avoid interpretation biases.
  • Document comparisons of previous reports.
  • Clearly document the absence of prior studies (e.g., “no prior films taken,” or “no previous films are available”) and any attempts made to obtain them.
• Build redundancy into the system (e.g., use double reads or computer-aided detection).
• Stay current with breast cancer diagnostic advances.
• Comply with current clinical guidelines when appropriate.

Thirty-eight states are considering, have passed, or have rejected mandated dense breast tissue notification.⁸ An interactive map of the status of state breast density notification laws is available after free registration from Diagnostic Imaging. Additional breast density notification resources are available from the California Breast Density Information Group.

In March 2019, the U.S. Food and Drug Administration (FDA) proposed an update to the Mammography Quality Standards Act (MQSA) that would require providers to use standardized reporting language to notify patients of their individual breast density status. The FDA was accepting public comment through June 26, 2019.

References

1. National Cancer Institute. “Mammograms Fact Sheet.” (accessed 10/1/2019)

2. National Cancer Institute. "Dense Breasts: Answers to Commonly Asked Questions." Updated: September 7, 2018. (accessed 10/1/2019)

3. Muttarak M, Pojchamarnwiputh S, Chiwun B. Breast carcinomas: why are they missed? Singapore Medical Journal. 2006;47(10):851-857

4. Berlin L. Radiologic Errors and Malpractice: A Blurry Distinction. AJR. 2007; 189:517–522

5. Yousem DM. Malpractice: What the Thinking Radiologist Should Know. American College of Radiology. (accessed 10/1/2019)

6. Raskin M. Survival Strategies for Radiology: Some practical Tips on How to Reduce the Risk of Being Sued and Losing. AJR. 2006; 3:689-693

7. Dense Breast Tissue and Screening — Radiology Today Interview With Carol H. Lee, MD, FACR. Radiology Today. 2014 Jan:15(1)30. (accessed 10/1/2019)

8. DenseBreast-info.org. Breast Density Notification Laws by State Interactive Map. (accessed 10/1/2019)